21 CFR 111 Dietary Supplement GMP Overview - Intro (8-hours)

The purpose of this training is to understand the requirements for the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplement Standard and how to implement them at your facility. The standard is based on 21 CFR 111 requirements, other regulations (normative references), retailer criteria, and industry best practices. The criteria in this standard were structured to follow a seven (7) systems approach. In this training we will discuss what you will need to prepare in preparation for an audit at your dietary supplement manufacturing facility.

We will not be discussing the need for documented procedures and evidentiary records in depth as this is well documented within the standard as well as the prerequisite Dietary Supplement GMP Training and is always best practice.

The training is divided into two sections:

Section 1

• Context of the organization- this includes requirements for implementing a quality management system (QMS) as well as regulatory requirements.
• Leadership- this includes requirements for management to demonstrate commitment to the QMS, such as assigning roles and responsibilities throughout the organization.
• Planning, which includes requirements for planning for the ongoing function of the QMS.

Section 2

• Support - includes requirements for management of resources for the QMS. This includes buildings and infrastructure, human resources, and control of documents.
• Operation - includes requirements on planning and creating of the product.
• Performance evaluation - includes requirements for monitoring the QMS and evaluation of the product.
• Improvement - includes requirements for taking corrective action for product or process nonconformities, and actions to make the QMS better over time.

Key Learning Objectives

• You will learn the structure of the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplements Standard, with a detailed overview of each section of the standard.
• You will learn the specific requirements of the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplements Standard.
• You will understand the intent of the required programs and elements of the 455-2 standard from the NSF/ANSI 455-2- ARG - Audit Requirements Guidance for Good Manufacturing Practices for Dietary Supplements.
• You will learn best practices on how to implement the required programs and elements of the standard.
• You will learn what documentation is necessary to demonstrate compliance with the standard at your facility.

Who Should Attend?

• Attend this training if you work in:
• Management
• Manufacturing
• Quality control/assurance
• Packaging
• Marketing Laboratory operations
• Auditing
• Suppliers and distributors
• Regulatory affairs

Dates: May 21-23, 2025
Time: 1:00 P.M to 5:00 P.M Eastern Time

Cost: $1000.00
Course Prerequisites: None

*Register 3 or more attendees from the same company and receive a 10% discount off each registration*

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Description:

Vendor Qualification and Audit Training

Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. But FDA does not provide much guidance on how to qualify vendors. This class is designed for to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers. Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. The auditing skills and techniques learned in this course are independent of the type of auditing or the standard being audited. These skills and techniques will be useful when conducting internal audits as well as performing audits of suppliers

Day 1: March 24, 2025 1:00pm-5:00pm Eastern Time
Day 2: March 25, 2025 1:00pm-5:00pm Eastern Time

Cost: $800.00

Completion of the course means being in attendance 95% of the log in time. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

This training course is 16-Hours split over 3-days. FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs. This course provides a basic understanding of CGMPs and the responsibilities expected for various individuals and groups within the company. Participants will learn how to apply CGMP principles to specific situations. The course is interactive, with hands-on exercises including case-studies from recent Warning Letters.

As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Course Prerequisites: None

Date: March 26, 2025

Time: 12:00 pm to 5:00 pm Eastern Time

Date: March 27, 2025

Time: 12:00 pm to 5:00 pm Eastern Time

Date: March 28, 2025

Time: 12:00 pm to 6:00 pm Eastern Time

Cost: General Registration $1200.00

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.